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Dictionary of Evidence-based Medicine.pdf

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<strong>Dictionary</strong> <strong>of</strong> <strong>Evidence</strong>-<strong>based</strong> <strong>Medicine</strong> 125<br />

that prices, pr<strong>of</strong>its and costs are within acceptable limits. Historically,<br />

pr<strong>of</strong>its <strong>of</strong> about 20% are deemed reasonable and aggregate expenditure on<br />

sales promotion is limited to 9% <strong>of</strong> total sales. For comparison most large<br />

established pharmaceutical companies spend about 10% <strong>of</strong> total sales<br />

on research and development. The PPRS system is meant to be voluntary<br />

but clearly the perceived penalty attached to non-acquiescence ensures<br />

that most companies adhere to the scheme. The complexity <strong>of</strong> transfer<br />

pricing by multinationals makes this system difficult to police. The Public<br />

Accounts Committee reviews the agreement at regular intervals. There is<br />

much controversy about the value <strong>of</strong> PPRS. The UK government would<br />

point out that its application has led to a thriving pharmaceutical industry<br />

but others have argued that it is a disincentive to investment in research<br />

and development (Green DG, Brown P, Burstall ML et al. (1997) Should<br />

pharmaceutical prices be regulated Institute <strong>of</strong> Economic Affairs, Health and<br />

Welfare Unit, London).<br />

Practice guidelines<br />

Practice guidelines are systematically developed statements to assist practitioner<br />

and patient decisions about appropriate health care for specific<br />

clinical circumstances (Field MJ, Lohr KN (eds) (1990) Clinical practice guidelines:<br />

directions for a new program. National Academy Press, Washington DC).<br />

Pragmatic trial (see under Intention to treat analysis)<br />

P re-certification<br />

Pre-certification refers to the system whereby clinicians, usually within a<br />

managed care system, must seek permission to provide specific services to<br />

patients before initiating such treatment.<br />

Pre-consent randomization design (see under Post-randomization<br />

consent design)<br />

Prescribing analysis and cost data (see PACT data)<br />

Prescription Drug User Fee Act 1992<br />

The Prescription Drug User Fee Act 1992 (PDUFA) is a US law which<br />

authorizes the US Food and Drug Administration to levy user fees on

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