Candy Day candy@healthlink.org.za
Developing evidence-based practice as a routine way of working for health services is possible and will improve the care received by patients if properly co-ordinated (Interim report of PACE program, E-drug conference, 26/11/97).
This is also one of the guiding principles of the National Drug Policy ( http://www.sadap.org.za/ndp ) and foundational in the development of the Essential Drugs List ( http://www.sadap.org.za/edl ).
Clinicians looking after individual patients increasingly need to base their judgments on the best evidence available. It is therefore also the case that those who make decisions about groups and populations will require access to the best possible evidence to inform their judgment. As pressure increases on resources, decision-makers will be forced to take the evidence about effectiveness, cost-effectiveness and safety into account to a much greater degree. In addition to this, increasingly well organised and informed groups of patients and populations will demand to know the evidence on which decisions are based. They will compare this evidence to that available to the public through the Web and other sources in years to come. In the past, too many decisions have been based solely on the values of the society or population and with the context of the resources available, and shaped by the hunches and opinions of decision-makers about effectiveness and cost-effectiveness. As the pressure increases opinion-based decision-making will have to be replaced by evidence-based decision-making.
A recent discussion about the widespread use of mefenamic acid in children on E-drug (Jan 98) <http://www.healthnet.org/programs/edrug.htm> illustrates some of these issues: |
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| Regarding the management of fever in children,
a booklet was created that summed up information obtained from various international
sources; among these were web sites, recent studies, and reference texts. What was found
is that, as others have already mentioned, paracetamol (acetaminophen) is the safest
antipyretic available for children. Ibuprofen is an alternative, but it is not considered
safe by all countries… The Micromedex Drug Information System states that mefenamic acid "is not suggested in children less than 14 years old, however, it has been given … In Italy, both diclofenac (Voltaren) and mefenamic acid are not indicated for antipyretic use. Furthermore, the overall use of diclofenac is not recommended for children less than 14 years of age. |
The discussion on mefenamic acid and its use
in children illustrates an important issue in healthcare. I know that mefenamic acid is
popular in South Africa, for example, and is widely prescribed for children with fever.
This happens despite the unfavorable risk/benefit ratio of mefenamic acid, the
availability of safer drugs, and the doubts regarding the use of antipyretics in children
with moderate fever. Doctors prescribe this drug probably because they have seen its positive effect in their practices, and mothers routinely ask for mefenamic acid when their children are ill. So much for "evidence-based" medicine. If doctors and other health care personnel have not seen adverse effects in patients using this drug, and the patient (in the case of children, the parent) does not report any, there does not seem a need for changing to a "safer" drug. The question of whether the risk of using the drug is worth the benefit of course remains. Information gained from the "real-world" situation in doctor's practices should be given more prominence and be accepted as "evidence" if recorded in a systematic and reproducible way. Meta-analysis (of clinical trials) and other techniques used in the practice of evidence-based medicine, would probably not give a satisfactory answer to the question of the rationality of the use of mefenamic acid in children with fever. (The same argument can of course be used for the use of diclofenac in children). I agree, however, that the doubt about its safety should be sufficient to motivate prescribers to not use it in children. Samuel Wagner Research Specialist in Pharmaceutical Economics |
Sam Wagner makes several important points in
his very useful comments. The reason we don't accept "real life" experience as "evidence" is precisely because it is not systematic and reproducible. We need in clinical studies to have a certainty that the effects we are observing are due to the specific action we have taken. In the situation that Sam describes this is not possible because of many factors like external influences, observer bias, uncertain end points, etc. No matter how much subjective results are obtained, they can never be converted into objective results. The next point he makes is a valid one about the ratio of risk and benefit. The perceived risk of giving these medicines is low compared to the apparent benefits accrued. If this wasn't the case, the medicines would not be prescribed or administered. It must be stressed that these are based on perceptions. It may well be that the actual risks are low - present but low in as much as they are not often observed. However we also know that the actual benefits are also low. We are interested in the rational use of medicines and must continue to preach this message. Resources used in the management of patients in the way described may deny the use of resources in other areas of health care or treatment. These opportunity costs when included in the analysis may make it more imperative that we do not treat patients in this way. Tim Dodd Director of Pharmacy, Pakistan |
This discussion highlights how easily one may continue the irrational use of medicines due to prescriber or patient pressure, or simply habit, and forget to question or research the rationale of the treatment.
Finding the Evidence
A quick check to see if there is any evidence in your chosen topic area could involve the following steps:
These will be discussed in greater detail in the next issue.
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