Dictionary of Evidence-based Medicine.pdf
Dictionary of Evidence-based Medicine.pdf
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